MULTICENTER, DOUBLE-BLIND, RANDOMIZED, CONTROLLED WITH PLACEBO STUDY WHOSE PURPOSE IS TO EVALUATE THE EFFECT OF COMPLEMENTARY TREATMENT WITH ROFECOXIB (MK-0966) IN THE LOCALIZED PROSTATE CANCER
- Conditions
- -C61 Malignant neoplasm of prostateMalignant neoplasm of prostateC61
- Registration Number
- PER-053-01
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient understands and is able to carry out the procedures and agrees to participate in the study by providing written informed consent.
• The patient is male> 40 years of age who has undergone a radical prostatectomy with attempted healing of the histologically confirmed pathological condition T2 to T3a, NO, MO (Appendix 4) of an adenocarcinoma of the prostate. Patients may NOT have received complementary hormone therapy.
• The patient has completed a surgical therapy within 12 weeks prior to the administration of the drug.
• The patient has a Gleason score of 7 with positive surgical margins or a sum of Gleason Score 3> to 8 out of 10 with negative surgical margins.
• The patient has an O-1 performance status in the GOCE.
• The patient has a presurgical APE of> 4.0 mg / mL and has an APE of <0.2 mg / mL after radical prostatectomy and within 2 weeks prior to administration of the drug.
• The patient after an appropriate clinical evaluation (which includes a previous bone scan and tests) has been ruled out of a diagnosis of recurrent prostate cancer.
• The patient is mentally or legally incapacitated at the time of the study or has a history (within 2 years prior to study entry) of alcohol or drug abuse or is a user (including recreational use) of an illicit drug.
• The patient has a history of gastric, biliary or small bowel surgery that causes malabsorption.
• The patient has a history of esophageal or gastric surgery or active gastrointestinal ulcer. (Patients with a history of simple perforation surgery greater than 3 months before the start of the study can participate in the study, and patients with a history of a simple hiatal hernia healed can participate in the study.)
• The patient has a history of inflammatory bowel disease.
• The patient has a history of liver disease / active hepatitis.
• The patient has a history of hemorrhagic diathesis.
• The patient suffers from uncontrolled hypertension. P ^ ota: patients suffering from medically controlled hypertension (diastolic blood pressure <95 mmHg, systolic blood pressure <165) may participate.]
• The patient has participated in another study (which includes drugs approved by the agency for an unapproved indication) of a research agent within 4 weeks prior to the administration of the drug.
• The patient has a history of some disease or condition that, in the opinion of the investigator, could confuse the results of the study or could create additional risks for the patient.
• The patient has received radiation therapy directed to the tumor, chemotherapy, immunological therapy, therapy of modification of the biological response or hormonal therapy. However, patients who have received replacement thyroid therapy (within 4 weeks prior to the administration of the drug) may be included.
• It is anticipated that the patient will require hormone therapy, immunological therapy, biological response modification therapy, radiation therapy, surgery or chemotherapy before APE recurrence of prostate cancer.
• The patient has a history (within 5 years prior to the administration of the drug) of another cancerous tumor excluding the basal / squamous cell carcinoma of the skin in Stages I or II.
• The patient has evidence of renal function compromise, defined as creatinine cleavage of <30 mlVmin.
• The patient has an absolute neutrophil count of <1500 / mm3, platelet count <100,000 / mm3, hemoglobin> 9 gm / dL, bilirubin> 1.5 times the upper limit of normal, ALT or AST> 2 times the limit superior normal or cratinin> 1.5 times the upper limit of normal.
• The patient uses NSAIDs or coxibs with or without a prescription (including CELEBRBX [celecoxib, Pfizer, Inc.], VIOXX) in chronic form (defined as> 7 days for one month before entry into the study). The use of NSAIDs, including CELEBREX ™ or VIOXX ™, at any time during the course of the test, is prohibited unless patients taking <100 mg / day of aspirin can be included in the study. Also, patients who have or develop the need to take cardioprotective doses of aspirin after randomization are allowed to use doses of <100 mg / day of aspirin.
• The patient is allergic or hypersensitive (for example, bronchoconstriction in association with nasal polyps) to aspirin, naproxen or other NSAIDs.
• The patient has undergone alternative therapies with hormonal effects (eg PC-SPES and / or medicinal herbs) 1 month before the administration of rofecoxib or placebo or plans to undergo alternative therapies with hormonal effects (eg PC
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Recurrences defined by an elevated PSA of at least 0.2 mg / mL, occurring before the end of the study.<br>Measure:Incidence of recurrent prostatic cancer<br>Timepoints:before the end of the study.<br>;<br>Outcome name:A secondary analysis will be carried out to calculate and compare the time elapsed until the recurrence defined by the PSA for each treatment group.<br>Measure:Safety and general tolerability of the treatment<br>Timepoints:At the end of treatment<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:recurrence is defined as: (i) some clinical recurrence (local and systemic) and (ii) all recurrences (local / systemic and PSA)<br>Measure:Indexes of recurrence between groups<br>Timepoints:During treatment<br>;<br>Outcome name:Registry of effects of rofecoxib or placebo treatment on biochemical markers<br>Measure:Effects of rofecoxib or placebo treatment on biochemical markers<br>Timepoints:During treatment<br>